Reported Sep 9, 2015 · Terminated
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker…
Stryker Instruments Div. of Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- Neptune 2 Waste Management System Docking Station (120V and 230V)
- New and Refurbished Product UsageThe Stryker Docking Station (Docker) is a component of the Neptune 2 Waste Management System. The Stryker Rover, another component of the system, is a mobile unit used to suction and collect fluid waste and surgical smoke from a surgical site in an operating room. After collection, the Docker is mated to the Rover and the emptying of fluid waste and cleaning of the canisters occurs automatically. The Actuator Assembly is a component located within the Docker which consists of the fluid coupling parts under a spring loaded cover
- Intended UseThe Neptune 2 Waste Management System is intended to be used in the operating room, pathology, surgical centers, and doctor s offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautery or laser devices
- Lot codes and dates
- Manufacturer Part Numbers0702-014-000 & 0702-014-000U, Manufactured between January 15, 2015 and June 3, 2015; Serial#s:
393 of 393 codes
102670096315104089631503405703143380974314338096631430301263143030127314338097131513817133143350339314338097931433809833143030122314303012431433503413143430749314349069931504406063142950618315044061731504405953150440605314295061031504406133150440614315100181431504405923150440596315044059731434906973143070769314335033631433503433151460069315049116931504911713151470607315147060831514100683151460071314295061131429506153151292085314195024531420204963151381712314181107431511700023151170003315138171131514100663150440601315063161031504911613150491162315138171531430301433142970550311068003031429705483
- Manufacturer Part Numbers0702-014-000 & 0702-014-000U, Manufactured between January 15, 2015 and June 3, 2015; Serial#s:
- Amount recalled
- 524, 237 of these are non-conforming
Where it was sold
Why it was recalled
The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak between the Rover and Docker couplers during docking or leaking from the Rover coupler after docking. The potential hazard is waste fluid and/or fresh water dispensed from the Neptune 2 Rover at the incorrect time.
This product could cause temporary or reversible health problems — stop using it.
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